• Set up, operating, and cleaning laboratory equipment used to support production of intermediate, raw material, and finished products for API, medical device raw material components, and other products as directed; complete all associated support activities in the laboratory.
• Review peer laboratory data to ensure accuracy and completeness.
• Demonstrate and develop experience on HPLC, UPLC, Karl Fischer, UV analysis, NIR, and other analytical techniques and train other laboratory personnel on these techniques.
• Develop skills to troubleshoot and perform minor maintenance, calibration, and repair of laboratory instrumentation.
• Provide input on investigations (OOS, OOT, invalid assays, and other lab-related non-conformances including investigations of audit observations) and support the implementation of relevant CAPAs and monitor effectiveness of CAPAs and as needed.
• Carry out duties in a safe manner and within compliance with all state and federal regulations and guidelines including FDA, ISO, EPA, OSHA, and DEA, while adhering to all company and site policies and procedures.
• Perform other duties as assigned by site leadership.

• A High School Diploma with 3 years of experience in a Quality Control Laboratory (FDA or USDA regulated environment) -OR- a Bachelor’s degree with 0 years’ experience in a Chemistry / Biochemistry / Environmental field (no Computer Science) is required.
• Experience applying mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlational techniques, sampling theory, and/or factor analysis is preferred.
• Experience identifying and defining problems, collecting data, establishing facts, and making scientific-based conclusions is preferred.
• Knowledgeable of FDA/EMEA regulatory requirements applicable to pharmaceuticals and medical device is preferred.
• Experience in Lab Operations and/or Quality processes/systems in a GMP Lab setting is preferred.
• Experience working with Lab Systems or processes such as eLIMs, TrackWise, Non-conformances, and/or Change Control is preferred.
• Familiarity with a variety of laboratory equipment, such as: GC, HPLC, UPLC, and/or Karl Fisher is preferred.
• Availability to work rotating hours of 6:00am to 4:30pm and 2:00pm to 12:30am shifts including weekends; overtime (on a scheduled or emergency basis) to support shift operations required.

Job Summary